Apparatus and methods for deployment of a modular stent-graft system
The present invention provides a modular stent-graft system. In one embodiment, a prosthesis comprises a first tubular graft comprising a layer of graft material, one lumen extending therein, and a first fenestration extending through the layer of graft material. A layer of fenestration covering material attaches to the layer of graft material. The layer of fenestration covering material is disposed in the lumen of the first tubular graft and partitions the first fenestration from the lumen of the first tubular graft. A first non-stented opening is disposed proximal to the first fenestration and communicates with the first fenestration between the layer of graft material and the fenestration covering material. In use, a proximal end of a second tubular graft sealably engages the first non-stented opening, and the second tubular graft further extends through the first fenestration and into a branch vessel.
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This application is a continuation-in-part of U.S. Utility patent application Ser. No. 12/332,904, filed Dec. 11, 2008 and entitled “Low Profile Non-Symmetrical Stent,” which claims priority to U.S. Provisional Patent Application Ser. No. 61/016,753, filed Dec. 26, 2007, each of the above-referenced disclosures are hereby incorporated by reference in their entireties.
BACKGROUNDThe present invention relates generally to apparatus and methods for treating medical conditions, and more specifically, to stents and stent-grafts for use in body vessels to treat those medical conditions.
Stents may be inserted into an anatomical vessel or duct for various purposes. Stents may maintain or restore patency in a formerly blocked or constricted passageway, for example, following a balloon angioplasty procedure. Other stents may be used for different procedures, for example, stents placed in or about a graft have been used to hold the graft in an open configuration to treat an aneurysm. Additionally, stents coupled to one or both ends of a graft may extend proximally or distally away from the graft to engage a healthy portion of a vessel wall away from a diseased portion of an aneurysm to provide endovascular graft fixation.
Stents may be either self-expanding or balloon-expandable, or they can have characteristics of both types of stents. Various existing self-expanding and balloon-expandable stent designs and configurations comprise generally symmetrical end regions including one or more apices formed of nitinol or another alloy wire formed into a ring. The apices commonly comprise relatively acute bends or present somewhat pointed surfaces, which may facilitate compression of the stent to a relatively small delivery profile due to the tight bend of the apices. Although having this advantage, in some situations, such relatively acute or pointed apices may be undesirable, in particular in vessel anatomies that are curved or tortuous such as, for example, the thoracic aorta.
The thoracic aorta presents a challenging anatomy for stent grafts used to treat thoracic aneurysms or dissections. The thoracic aorta comprises a curve known as the aortic arch, which extends between the ascending thoracic aorta (closet to the heart) and the descending thoracic aorta (which extends toward the abdominal aorta). Thoracic stent grafts are used to exclude thoracic aortic aneurysms. A stent graft's ability to conform to the tortuous anatomy of the aortic arch is a major concern. Current designs sometimes lack the desired sealing ability at the proximal end of the stent graft (closest to the heart). Also, current thoracic devices present a relatively large profile which, with some patients' anatomies may be problematic. Finally, many current stents have relatively acute points that may prevent them from being used in the aortic arch for fear of undesirable interaction with the artery wall after an extended amount of time in the patient.
Therefore, a generally nonsymmetrical stent having at least one relatively rounded apex that is less invasive in an expanded state than stents with more acute apices may alleviate the above problems, while providing an improved compliance to the aortic arch and increased radial force if used as a sealing and/or alignment stent, as well as a desirable ability to be crimped to a readily introducible diameter.
As one particular example, type-A thoracic aortic dissection (TAD-A) is a condition in which the intimal layer of the ascending thoracic aorta develops a tear, allowing blood to flow into the layers of the aortic wall, causing the development of a medial or subintimal hematoma. TAD-A is associated with a strikingly high mortality rate (about one-fourth to one-half of victims die within the first 24-48 hours). The only current treatment for TAD-A is open surgery, where the chest is opened, the aorta is clamped, and a vascular prosthesis is sewn in place. Operative mortality rate for this procedure may be around 10%. Endovascular treatment of TAD-B (which affects the descending thoracic aorta) has been effective in reducing short-term and longer term mortality. Therefore, it is desirable to provide an endovascular device configured to address the anatomic challenges of the thoracic aorta.
SUMMARYThe present invention provides apparatus and methods for deployment of a modular stent-graft system. In one embodiment, a prosthesis comprises a first tubular graft comprising a layer of graft material, at least one lumen extending longitudinally therein, and a first fenestration extending through the layer of graft material. A layer of fenestration covering material attaches to the layer of graft material. The layer of fenestration covering material is disposed in the lumen of the first tubular graft and partitions the first fenestration from the lumen of the first tubular graft. A first non-stented opening is disposed proximal to the first fenestration and communicates with the first fenestration between the layer of graft material and the fenestration covering material. In use, a second tubular graft sealably engages the first non-stented opening, and the second tubular graft further extends distally through the first fenestration and into a branch vessel.
In an alternative embodiment, a plurality of fenestrations extend through the layer of graft material. The layer of fenestration covering material is attached to the layer of graft material and partitions the plurality of fenestrations from the lumen of the first tubular graft. In use, the second tubular graft sealably engages the first non-stented opening, and the second tubular graft further extends distally through one of the plurality of fenestrations and into the branch vessel.
Advantageously, a physician may insert the second tubular graft in a proximal to distal direction through the first non-stented opening, through any of the desired plurality of fenestrations, and then into a branch vessel. The physician may select a desired fenestration based on the particular anatomy of a patient during use, e.g., the fenestration that best facilitates alignment or entry of the second tubular graft into a branch vessel. Regardless of the fenestration selected, a fluid seal is maintained at the point of the first non-stented opening by deployment and expansion of the second tubular graft into sealing engagement with the first non-stented opening.
Other systems, methods, features and advantages of the invention will be, or will become, apparent to one with skill in the art upon examination of the following figures and detailed description. It is intended that all such additional systems, methods, features and advantages be within the scope of the invention, and be encompassed by the following claims.
The invention can be better understood with reference to the following figures and description. The components in the figures are not necessarily drawn to scale, emphasis instead being placed upon illustrating the principles of the invention. Moreover, in the figures, like referenced numerals designate corresponding parts throughout the different views.
In the present application, the term “proximal” refers to a direction that is generally closest to the heart during a medical procedure, while the term “distal” refers to a direction that is furthest from the heart during a medical procedure. Reference throughout is made to proximal and distal apices, but those of skill in the art will appreciate that the proximal-distal orientation of stents of the present invention may be reversed without exceeding the scope of the present invention.
As shown in
The asymmetric stent may be configured such that, when used with a graft, it will provide a sufficiently strong radial force at the graft's end openings to hold the graft material open against the artery wall. Also, the stent is intended to be short in length so that the graft will include flexibility sufficient to accommodate a patient's anatomy. This combination of flexibility and strong radial force provides an improved seal between the graft and artery wall. In addition, enhanced flexibility is provided as well, particularly when one or more stents are used to provide short segments and better accommodate curves.
In these and other examples, the ratio of the proximal apices' radius of curvature to the distal apices' radius of curvature may be about 2.6:1 to about 18:1 , and desirably may be about 6:1. The outer circumference of the stent 200 preferably is generally consistent such that, in this configuration, a solid outer face around the stent 200 would form a cylinder, although the stent will most preferably provide compliance with a surface less smooth than a cylinder.
The rounded points on the stent may protrude from the graft material only a small amount as is shown in
A layer of fenestration covering material 612 is attached to the layer of graft material 619, disposed in the lumen 613 of the first tubular graft 610, and partitions the first fenestration 611 from the lumen 613, as shown in
In use, a second tubular graft 614, comprising proximal and distal ends and a lumen extending longitudinally therebetween, sealably engages the first non-stented opening 625, as best seen in
As shown in
Further, the prosthesis may comprise a second fenestration 631 and a second non-stented opening 645 disposed proximal to the second fenestration 631, as best seen in
In one embodiment, the first and/or second non-stented openings 625 and 645 are disposed about even with a proximal end of the first tubular graft 610. Further, the first and second non-stented openings 625 and 645 may be positioned between about 130 to about 230 degrees apart from one another around a circumference of the layer of graft material 619, and more preferably about 180 degrees apart, as depicted in
While the second and third tubular grafts 614 and 634 are shown as generic tubes, the second and/or third tubular grafts 614 and 634 may comprise first and second stents disposed at the proximal and distal ends, respectively. The first stents disposed at the proximal ends may expand into engagement with the non-stented openings 625 and 645, thereby providing a sealed conduit such that blood only flows distally into the main lumen 613 or one of the second and third tubular grafts 614 and 634. The second stents disposed at the distal ends of the second and third tubular grafts 614 and 634 may anchor into engagement with a branch vessel, such as the renal arteries.
Further, in the embodiment of
Referring to
As in the embodiment of
Advantageously, in this manner, a physician may insert the second and/or third tubular grafts 614 and 634 in a proximal to distal direction through the non-stented openings 625 and 645, through any of the desired plurality of fenestrations 611′, and then into a branch vessel. The physician may select a desired fenestration 611′ based on the particular anatomy of a patient during use, e.g., the fenestration 611′ that best facilitates alignment or entry of the second and/or third tubular grafts 614 and 634 into a branch vessel. Regardless of the fenestration 611′ selected, a fluid seal is maintained at the point of the non-stented openings 625 and 645 by deployment and expansion of the second and third tubular grafts 614 and 634 into sealing engagement with the non-stented openings 625 and 645.
Referring to
Stent examples of the present invention may be constructed of NiTi alloys or other materials presently known or yet to be developed, all within the scope of the present invention. The stents preferably are made from Nitinol wire and will therefore be MRI compatible. In another preferable embodiment, a stent may be made from a laser-cut Nitinol cannula, effectively rendering it a seamless or nearly-seamless wire-like construction. Nitinol's superelastic properties will facilitate the stents ability to be crimped down into a low profile delivery system.
While various embodiments of the invention have been described, it will be apparent to those of ordinary skill in the art that many more embodiments and implementations are possible within the scope of the invention. Accordingly, the invention is not to be restricted except in light of the attached claims and their equivalents. Moreover, the advantages described herein are not necessarily the only advantages of the invention and it is not necessarily expected that every embodiment of the invention will achieve all of the advantages described.
Claims
1. A prosthesis comprising:
- a first tubular graft comprising a layer of graft material, at least one lumen extending longitudinally therein, and a plurality of fenestrations extending through the layer of graft material;
- a layer of fenestration covering material attached to the layer of graft material, wherein the layer of fenestration covering material is disposed in the lumen of the first tubular graft and partitions the plurality of fenestrations from the lumen of the first tubular graft;
- a first non-stented opening disposed proximal to the plurality of fenestrations and communicating with at least one of the plurality of fenestrations between the layer of graft material and the fenestration covering material; and
- a second tubular graft comprising a proximal end and a distal end and a lumen extending longitudinally therebetween,
- where the second tubular graft sealably engages the first non-stented opening, and the second tubular graft further extends distally through one of the plurality of fenestrations and is configured to extend into a branch vessel.
2. The prosthesis of claim 1, where the layer of fenestration covering material comprises a distal segment that is flared relative to a proximal segment.
3. The prosthesis of claim 1, where the first non-stented opening is disposed about even with a proximal end of the first tubular graft.
4. The prosthesis of claim 1, where the first non-stented opening comprises a perimeter formed by a combination of the layer of graft material and the fenestration covering material, wherein less than half of the perimeter of the first non-stented opening is formed by the layer of graft material.
5. The prosthesis of claim 1, where the first non-stented opening comprises a perimeter formed by a combination of the layer of graft material and the fenestration covering material, wherein less than half of the perimeter of the first non-stented opening is formed by the fenestration covering material.
6. A prosthesis comprising:
- a first tubular graft comprising a layer of graft material, at least one lumen extending longitudinally therein, and a plurality of fenestrations extending through the layer of graft material;
- a layer of fenestration covering material attached to the layer of graft material, wherein the layer of fenestration covering material is disposed in the lumen of the first tubular graft and partitions the plurality of fenestrations from the lumen of the first tubular graft;
- wherein the layer of fenestration covering material comprises a distal segment that is flared relative to a proximal segment and wherein the flared distal segment generally surrounds the plurality of fenestrations extending through the layer of the graft material;
- a first non-stented opening disposed proximal to the plurality of fenestrations and communicating with at least one of the plurality of fenestrations between the layer of graft material and the fenestration covering material; and
- a second tubular graft comprising a proximal end and a distal end and a lumen extending longitudinally therebetween,
- where the second tubular graft sealably engages the first non-stented opening, and the second tubular graft further extends distally through one of the plurality of fenestrations and is configured to extend into a branch vessel.
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Type: Grant
Filed: Jul 22, 2010
Date of Patent: Mar 31, 2015
Patent Publication Number: 20100312326
Assignee: Cook Medical Technologies LLC (Bloomington, IN)
Inventors: Timothy A. M. Chuter (San Francisco, CA), Blayne A. Roeder (Lafayette, IN), Steven J. Charlebois (West Lafayette, IN)
Primary Examiner: Paul Prebilic
Application Number: 12/841,807
International Classification: A61F 2/06 (20130101); A61F 2/86 (20130101); A61F 2/07 (20130101); A61F 2/856 (20130101); A61F 2/915 (20130101); A61F 2/82 (20130101); A61F 2/848 (20130101); A61F 2/89 (20130101);